NCT03804619

Accelerated Intermittent Theta-Burst Stimulation for Opiate Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine whether multiple spaced sessions of intermittent theta-burst transcranial magnetic stimulation (iTBS) induce anti-depressant responses and reduce opiate cravings in adults with opiate use disorder (OUD). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.

Detailed description

The proposed study aims to investigate the effectiveness of aiTBS applied to either the L-DLPFC or the ACC for reducing SI in individuals with OUD and identify neural functional connectivity changes underlying treatment response. 30 individuals with OUD who endorse suicidal ideation will be recruited. The accelerated iTBS treatment will involve 10 daily sessions of iTBS. Stimulation will be delivered to either the ACC or the L-DLPFC for 5 consecutive days. Suicidal ideation, depressive symptoms and opiate misuse will be measured before and after the 5-day stimulation course. Functional magnetic resonance imaging (fMRI) scans will also be carried out before and after stimulation to examine aiTBS-induced changes in neural functional connectivity. Changes in suicidal ideation, depressive symptoms and opiate misuse will be measured using both clinician-rated and self-report assessments.

Conditions

• Opiate Dependence
• Suicidal Ideation
• Depression
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Accelerated intermittent theta-burst stimulation (aiTBS)	aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-11
• Completion: 2024-07-11
• First posted: 2019-01-15
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study